This blog is straight talk about quality assurance in the pharmaceutical industry. Not the technical aspects as much as the challenges faced by company management and their internal quality assurance professionals—sometimes side-by-side and often toe-to-toe.

Saturday, January 29, 2011

The Crack in the Wall: Unintended Consequences of Authority

I remember when I was a freshly minted executive taking a window tour of the manufacturing facility. While listening to a staff member talk about the operation, I idly traced my fingertip on an ever-so-slight mar on the finish of the corridor wall, as I was lost in thought. Little did I know the chain of events that this little action would set off. By the time of my next walk into the manufacturing facility, the entire corridor was freshly refinished.

It often is with executives: a simple word, glance or unconscious pause—in my case the mindless wandering of my fingertip—has surprising effects.

Once there was a pharma exec that stated flatly that certain software was the company standard. Little did he understand that an alternative software that was justified and better suited to a unique situation had been in play for months. But his comment set off a fury of activity by dozens of employees that worked tirelessly over months to convert the data and retrofit it into the awkward “company standard” at great expense and loss of precious time and effort to deliver on commitments to the FDA.

In another example, a pharma exec questioned the timing of a purchase order request for a controlled temperature chamber for the stability program. The simple question of timing sent the requisitioner back to try again next quarter. Little did the exec know that this equipment was needed to fulfill a commitment to the FDA, and that there was a six-month lead-time to acquire it.

With authority comes unintended consequences: the rank-in-file hesitates to question it or push back on it.

Rather than creating a situation where the humble creatures fear to approach the mighty Oz, it would be helpful if the executive would take time to invite conversation about the request.

However, shame on the person who fails to make the business case, and the person who walks away fully knowing the unintended consequences of the denied request.

I have never met a company executive—whether a blustery curmudgeon, or a charismatic leader—who does not speak the language of money; who does not abhor squandering resources; or who is not willing to pay now to avoid a problem with the FDA tomorrow—when the proper business case is made. (Well—almost never.)

And—where was QA during the countdown to the day of reckoning with the FDA?

Fear is alive a well in corporations. But fear is really the result of the lack of confidence; not being prepared; absence of skills to defend a point-of-view; and often haunting memories of boogey men of the past. In short, it’s lack of conviction and courage.

Debate is productive. Contrarians sharpen the decision process. We would all do well to encourage it.

John SnyderThe QA Pharm

The QA Pharm is a service of John Snyder & Company, Inc.John Snyder & Company, Inc., provides consulting services to companies regulated by the Food and Drug Administration. We help our clients to build an effective Quality Management System to enable reliable supply of quality products to their patients. We also help our clients to develop corrective action plans to address regulatory compliance observations and communication strategies to protect against accelerated enforcement action.Contact us at john@john-snyder.com.

Who am I?

I'm an observer of the pharmaceutical industry from inside and out for over 30 years. I've worked at the lab bench and on the management board. If you have a passion for Quality Assurance and understand the relationship of current Good Manufacturing Practices to your patients and your business, you will find a kindred spirit here.